Physiotherapy Intervention in Climacteric Women With Dyspareunia

NCT02804048 | Completed

• 1 other identifier: 13-0307
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To evaluate the effectiveness of physical therapy intervention techniques in the improvement of dyspareunia in climacteric women. Study design: This is a randomized controlled trial.

Conditions

Dyspareunia

Keywords

Dyspareunia; Pelvic floor muscles; Women

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain

  To evaluate the effectiveness of physiotherapy techniques using the analog pain scale.

  Seven meetings, twice a week, in which the first is the initial assessment and the seventh is the final evaluation totaling a maximum of one month treatment for each patient.

Secondary Outcomes (5)

• To evaluate the quality of life

  To evaluate the quality of life, using Cervantes Scale in climateric women in baseline and after four weeks of intervention

• To evaluate depression

  To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention

• To evaluate sexual function

  To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention

• To evaluate electrical activity of the pelvic floor muscles

  To evaluate electrical activity of the pelvic floor muscles, using Electromyographic biofeedback , in baseline and after four weeks of intervention

• To evaluate the pelvic floor muscle function

  To evaluate the pelvic floor muscle function, using PERFECT Scale in baseline and after four weeks of intervention

Study Arms (2)

Pelvic Floor Muscle Training

EXPERIMENTAL

superficial heat pelvic floor muscle intra vaginal manual therapy. PERFECT scale is applied in 5 sessions and based on the result of each assessment is performed the treatment plan with exercises of the pelvic floor muscles. It is performed manual therapy in iliopsoas, diaphragm and piriformis. From the fourth session, initiate treatment with electromyographic biofeedback based on the result of PERFECT scale.

Other: superficial heat pelvic floor muscle; Other: Pelvic Floor Muscle Training; Other: Manual therapy in iliopsoas, diaphragm and piriformis; Other: Intra Vaginal Manual therapy; Other: Electromyographic biofeedback

Low back

PLACEBO COMPARATOR

superficial heat low back Manual therapy in piriform, lumbar, iliopsoas and diaphragm.

Other: superficial heat low back; Other: Manual therapy in iliopsoas, diaphragm and piriformis

Interventions

superficial heat pelvic floor muscle OTHER

Superficial heat application in the pelvic floor muscle

Pelvic Floor Muscle Training

superficial heat low back OTHER

Superficial heat application in the low back

Low back

Pelvic Floor Muscle Training OTHER

Pelvic floor muscle training exercises

Pelvic Floor Muscle Training

Manual therapy in iliopsoas, diaphragm and piriformis OTHER

Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes

Low back; Pelvic Floor Muscle Training

Intra Vaginal Manual therapy OTHER

Intra Vaginal Manual therapy in the pelvic floor muscles

Pelvic Floor Muscle Training

Electromyographic biofeedback OTHER

Electromyographic biofeedback in the pelvic floor muscles

Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• dyspareunia complaint for at least six months
• visual analog scale of pain above 3
• trophic vagina

You may not qualify if:

• vaginal atrophy
• neurological disorders
• lack of cognition and understanding
• urinary tract infection and / or genital infections
• prolapse grade 2 and 3
• severe systemic disease
• performing physical therapy

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Clinical Research Center of HCPA

Porto Alegre, Rio Grande do Sul, 900035-903, Brazil

Location

MeSH Terms

Conditions

Dyspareunia

Interventions

Musculoskeletal Manipulations; Contraceptive Devices, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Contraceptive Devices; Equipment and Supplies

Study Officials

• Maria Celeste Wender, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: June 17, 2016
• Study Start: December 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10

Locations

BR (1)